Mindfulness Training for Depressed Older Adults Using Smartphone Technology: Protocol for a Fully Remote Precision Clinical Trial.
Abigail Schweiger, Thomas L Rodebaugh, Eric J Lenze, Katie Keenoy, Jason Hassenstab, Jeanne Kloeckner, Torie R Gettinger, Ginger E. Nicol
JMIR Research Protocols October 27, 2022 DOI: 10.2196/39233 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Open-label early-phase clinical trial Randomized Peer reviewed |
|---|---|
| Population | Adults 65 years and older with current depression, recruited anywhere in the United States |
| Intervention | Online mindfulness training |
| Duration | 10-week intervention; smartphone assessments 4 times daily for 4 weeks before and after the intervention; recruitment March 2019 to final assessments May 2022 |
| Topics | Depression Meditation |
| Keywords | Adult Aging Clinical trial Death Depressed Fully remote trial Intervention Mhealth Needs Older Online Precision medicine Preferences Session Smartphone Technology Training Treatment |
| Registration | NCT03922217 |
| Key findings | The paper describes Mindful MyWay, an open-label early-phase trial designed to test fully remote online mindfulness training in older adults with depression. It argues that smartphone-based, high-frequency assessment of symptoms, cognition, and preferences can support idiographic assessment and individually tailored intervention optimization, and that such early-phase testing should inform future randomized controlled trials within a precision medicine framework. Results are not reported; the paper focuses on design and lessons learned. |
Abstract
Precision medicine, optimized interventions, and access to care are catchphrases for the future of behavioral treatments. Progress has been slow due to the dearth of clinical trials that optimize interventions' benefits, individually tailor interventions to meet individual needs and preferences, and lead to rapid implementation after effectiveness is demonstrated. Two innovations have emerged to meet these challenges: fully remote trials and precision clinical trials. This paper provides a detailed description of Mindful MyWay, a study designed to test online mindfulness training in older adults with depression. Consistent with the concept of fully remote trials using a smartphone app, the study requires no in-person contact and can be conducted with participants anywhere in the United States. Based upon the precision medicine framework, the study assesses participants using high-frequency assessments of symptoms, cognitive performance, and patient preferences to both understand the individualized nature of treatment response and help individually tailor the intervention. Mindful MyWay is an open-label early-phase clinical trial for individuals 65 years and older with current depression. A smartphone app was developed to help coordinate the study, deliver the intervention, and evaluate the acceptability of the intervention, as well as predictors and outcomes of it. The curriculum for the fully remote intervention parallels the mindfulness-based stress reduction curriculum, a protocolized group-based mindfulness training that is typically provided in person. After consent and screening, participants download The Healthy Mind Lab mobile health smartphone app from the Apple App Store, allowing them to complete brief smartphone-based assessments of depressive symptoms and cognitive performance 4 times each day for 4 weeks prior to and after completing the intervention. The intervention consists of an introduction video and 10 weekly mindfulness training sessions, with the expectation to practice mindfulness at home daily. The app collects participant preference data throughout the 10-week intervention period; these high-frequency assessments identify participants' individually dynamic preferences toward the goal of optimizing the intervention in future iterations. Participant recruitment and data collection began in March 2019. Final end point assessments will be collected in May 2022. The paper describes lessons learned regarding the critical role of early-phase testing prior to moving to a randomized trial. The Mindful MyWay study is an exemplar of innovative clinical trial designs that use smartphone technology in behavioral and neuropsychiatric conditions. These include fully remote studies that can recruit throughout the United States, including hard-to-access areas, and collect high-frequency data, which is ideal for idiographic assessment and individualized intervention optimization. Our findings will be used to modify our methods and inform future randomized controlled trials within a precision medicine framework. ClinicalTrials.gov NCT03922217; https://clinicaltrials.gov/ct2/show/NCT03922217. DERR1-10.2196/39233.
Comparable studies
Other non-randomized and open-label trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Mindfulness-Based Stress Reduction in Relation to Quality of Life, Mood, Symptoms of Stress, and Immune Parameters in Breast and Prostate Cancer Outpatients Early-stage breast and prostate cancer patients | 2003 | Pre-post intervention study | n = 59 |
| Exploring self‐compassion and empathy in the context of mindfulness‐based stress reduction (MBSR) Community sample | 2010 | Pre-post intervention study | |
| Mindfulness-Based Stress Reduction Lowers Psychological Distress In Medical Students Second-year medical students | 2003 | Prospective nonrandomized cohort-controlled study | n = 302 |
| Intensive meditation training, immune cell telomerase activity, and psychological mediators. Retreat participants and matched controls | 2011 | Controlled trial with wait-list control group | n = 60 |
| The Effectiveness of Mindfulness Training for Children with ADHD and Mindful Parenting for their Parents Children aged 8-12 with ADHD and their parents | 2011 | Within-group waitlist controlled trial | n = 22 |
Citations in the library
Cites 5
- Group, One-on-One, or Internet? Preferences for Mindfulness Meditation Delivery Format and their Predictors Open Medicine Journal November 28, 2014
- Mindfulness intervention improves cognitive function in older adults by enhancing the level of miRNA-29c in neuron-derived extracellular vesicles Scientific Reports November 14, 2021
- Mindfulness-Based Stress Reduction for Older Adults With Stress Disorders and Neurocognitive Difficulties: A Randomized Controlled Trial. The Journal of Clinical Psychiatry July 2017
- Effectiveness of online mindfulness-based interventions in improving mental health: A review and meta-analysis of randomised controlled trials. Clinical Psychology Review April 1, 2016
- Mindfulness-based stress reduction for older adults with worry symptoms and co-occurring cognitive dysfunction. International Journal of Geriatric Psychiatry February 18, 2014